UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039201
Receipt No. R000044157
Scientific Title The exploratory research on improvements in the gastrointestinal function of the algae food intake a randomized, double-blind, placebo-controlled, parallel-group study
Date of disclosure of the study information 2020/12/01
Last modified on 2020/01/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The exploratory research on improvements in the gastrointestinal function of the algae food intake
a randomized, double-blind, placebo-controlled, parallel-group study
Acronym The beneficial effect of the algal food intake on human gastrointestinal function
Scientific Title The exploratory research on improvements in the gastrointestinal function of the algae food intake
a randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym The beneficial effect of the algal food intake on human gastrointestinal function
Region
Japan

Condition
Condition Healthy individual
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to investigate the efficacy of the intake of the algae food
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bowel Survey
Key secondary outcomes questionnaire
salivary sIgA concentration

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food Behavior,custom
Interventions/Control_1 algal food
Interventions/Control_2 placebo control food
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
59 years-old >=
Gender Male
Key inclusion criteria (1) Japanese, adult, male subjects aged =>20 years at the time of informed consent
(2) It is less than 25 more than BMI18.
(3) Individuals who has trends of diahhrea.
(4)Individuals who are healthy and are not suffered from a chronic malady.
(5)Those from whom a written consent can be obtained on a voluntary basis.
Key exclusion criteria (1)Individuals using medical products.
(2)Individuals who are prone to allergies for foods.
(3)Individuals who uses commercially available drug or a quasi-drugs, for the prevention and treatment of diarrhea with abdominal pain and abdominal discomfort, on a daily basis.
(4)Individuals who have a serious disease history or current medical history
(5)Individuals with serious anemia.
(6)Individuals who changed health food within the past 4 weeks or who started using it newly.
(7)Individuals who have irregular or disturbed life style such as night shifts.
(8)Individuals who are receiving treatment at a medical institution or those who judged to be in the relevant condition requires treatment.
(9)Individuals who have the following medical history : severe diseases (such as sugar metabolism, lipid metabolism, liver function, renal function, heart, circulatory organs, respiratory organs, endocrine system, the nervous system), or psychiatric diseases.
(10)Individuals who have history of alcohol and drug dependence.
(11)Individuals who have participated in other clinical studies within the past 4 weeks and/or who plan to participate in the other clinical tests .
(12)Individuals judged inappropriate for the study by the principal
Target sample size 16

Research contact person
Name of lead principal investigator
1st name Hiromu
Middle name
Last name Okazawa
Organization Tokyo University of Agriculture
Division name Faculty of Regional Environment Science
Zip code 156-8502
Address 1-1-1Sakuragaoka, Setagaya-ku, Tokyo
TEL 03-5477-2685
Email h1okazaw@nodai.ac.jp

Public contact
Name of contact person
1st name Hiromu
Middle name
Last name Okazawa
Organization Tokyo University of Agriculture
Division name Faculty of Regional Environment Science
Zip code 156-8502
Address 1-1-1Sakuragaoka, Setagaya-ku, Tokyo
TEL 03-5477-2685
Homepage URL
Email h1okazaw@nodai.ac.jp

Sponsor
Institute Tokyo University of Agriculture
Institute
Department

Funding Source
Organization KOBELCO ECO-SOULUTIONS CO.,LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo University of Agriculture
Address 1-1-1Sakuragaoka, Setagaya-ku, Tokyo
Tel 03-5477-2685
Email h1okazaw@nodai.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2020 Year 02 Month 19 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 20 Day
Last modified on
2020 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044157

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.